GUEST COLUMNISTS

• Good Distribution Practice Is Evolving — Here's How

  Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

• The 3 Phases of QRM – An Inspector's View

  Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

• ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy

  Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

• The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials

  Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

• A Case For Paying Allogeneic Cell Therapy Product Donors

  The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

• Protecting Intellectual Property In The Genomics Revolution

  Providing superior IP protection for genomics-related inventions already requires — and will require in the future — a more nuanced strategy combining patents, trade secrets, and copyrights.

• April 2025 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• Incorporating AI Tools Into Downstream Process Optimization

  Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.